FDA Adverse Event
Injury
Summary report: N
SCREW
MDR report key: 2211373
·
Received August 8, 2011
Report
- Report Number
- 2520274-2011-00542
- Event Type
- Injury
- Date Received
- August 8, 2011
- Report Date
- July 12, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CORRECTED EXPLANT DATE FROM (B)(6) 2011.
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
ONE OF THE SUPERIOR SCREWS IN A ZERO-P PLATE IMPLANTED AT C5-C6 WAS NOTED AS BACKING OUT. PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE LOOSE SCREW AND POSTERIOR FIXATION.
Description of Event or Problem · 1
THIS REPORT IS FOR A SCREW. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | SCREW | HWC | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |